Clinical Trial Project Manager at Eli Lilly and Company

Shanghai, Shanghai, China

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Use project management skills, processes and tools to develop and execute local, regional and/or global clinical trials
Understand the scope of work required to complete the clinical trial successfully, monitor status, and make changes per change control process
Develop and track trial enrollment plan by gaining alignment and integrating inputs across functions and geographies
Assess, identify, and monitor trial-level risks; incorporate scientific knowledge, trial process, and regional expertise to create integrated risk mitigation and contingency plan
Understand cross-functional, trial-level budget components; create and monitor overall budget and assumptions using financial tracking tools; network with business partners on budget status and changes
Demonstrate understanding of drug development process and inter-relatedness of cross-functional activities; understand impact of project decisions on the overall clinical trial
Be knowledgeable of the global and regional operating model; coordinate and facilitate obtaining regional input for study teams
Demonstrate ability to lead and influence in the midst of ambiguity
Apply problem-solving skills to daily issues with cross-functional study team (including vendors, affiliates/regions, global team members, and other business partners)
Network and leverage expertise to anticipate trial and regional issues, identify process breakdowns, assess situations, and propose proactive approaches to mitigate risks

Responsibilities

Partner with other organizations to coordinate and actively participate in Investigator Study Specific Training (ISSTs)/Affiliate Study Training (ASTs)
Drive and coordinate local, regional, and global cross-functional study team throughout study implementation, execution, and closure; empower team to meet deliverables, including issue management, contingency planning, and issue resolution
Be accountable for trial/regional enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET); partner with Regional Operations to achieve regional enrollment goals
Manage relationships and serve as single point of contact and central owner for trial communication to/from CPM Organization, Regional Clinical Operations, and Third Party Organizations (TPOs)
Identify and assist in developing continuous improvement activities based on trends such as industry, regulatory, new technology, etc
Manage TPO qualification process, selection, and oversight
Lead study team to support China Affiliate site inspection by partnering with China CSM and MQO representative
Partner with cross-functional team to facilitate the trial protocol development and maintenance process; look for opportunities to expand and deepen clinical trial process expertise
Serve as single point of accountability for the Trial Master File, working closely with functional record owners to ensure it is current and inspection ready at all times
Coach peers, cross-functional team members, and TPOs on aspects of clinical trial process and regional specifics

Skills

Project Management

Clinical Trials

Risk Management

Budget Management

Timeline Management

Cross-Functional Coordination

Issue Management

Contingency Planning

Enrollment Planning

Change Control

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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